Outsourcing

Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.

AGC Biologics is expanding manufacturing capacity at its Heidelberg, Germany, facility for plasmid DNA and messenger RNA.

Febles will oversee day-to-day aseptic manufacturing at Pharmaceutics International, Inc.

As interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases.

BioPharm International asked Vincent Colicchio, vice president, supply chain and external manufacturing at Dr. Reddy’s Laboratories, about how a lack of proper supplier oversight can impact the pharmaceutical industry and the drug supply chain.

Quotient Sciences is investing £6.3 million ($8.68 million) into their drug substance manufacturing capabilities.

Almost half of pharmaceutical industry profits continue to come from biopharmaceuticals.

AGC Biologics has broken ground on a new multipurpose facility in Copenhagen, Denmark, that will increase capacity.

Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.

Biotage’s new facility in Cardiff, UK, will produce lipids using large-scale flash purification.

The CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.

Scenario modeling informs planning for current and future manufacturing needs.

Manufacturers should consider the benefits and risks of contract packaging for stability studies.

LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.

The extended manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel Tau antibody therapeutic that targets Alzheimer's disease and traumatic brain injury.

Selexis and KBI Biopharma will use integrated services to advance Immatics’ TCR bispecifics drug development program to the IND stage.

CMOs and CDMOs adjust business processes as demand for COVID-19 treatments and non-pandemic related therapies puts pressure on the bio/pharma industry.

CDMO Yposkesi will increase its current gene therapy vector capacity through French government’s “Plan de Relance” scheme.

The companies have entered into an agreement to develop processes for a novel immunotherapy protein.

The companies will utilize the Cocoon Platform for clinical point-of-care manufacturing.

VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.

Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and development time efficiencies.

The expected growth of the global bio/pharmaceutical market is pushing for the continued evolution of the CDMO arena.